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Completed

NCT Number: NCT03795948

Patient Reported Outcomes in Stroke Care

The presented study is an explorative prospective study. First, it focusses on the longitudinal analysis of outcome quality in stroke treatment (12 months). Particularly, it addresses patient reported quality of life after inpatient stroke treatment and influencing factors. Second, it focusses on the feasibility and acceptance of a standard set of measures capturing outcome quality of medical care in stroke patients.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, University Medical Center Hamburg-Eppendorf (UKE)

Hamburg, 20246, Germany

About this study

With a shift in focus to patient-centered health care and a constant effort to improve the quality of treatment, the role of the patient's perception of his/her medical care becomes essential. Patient reported outcome measures (PROMs) are among the most adequate instruments for assessing the patient's perspective on symptom load, functional status, and quality of life. After stroke, patients not only suffer from objectively scaled and measurable symptoms and impairments but also experience dramatic changes in everyday routine and quality of life.

In this project, a standardized outcome measurement, including PROMs, for stroke patients is used.

This stoke standard set was developed by the International Consortium for Health Outcomes Measurement (ICHOM; www.ICHOM.org); an international, interdisciplinary and inter-professional expert group with the contribution of patient representatives, aiming to create a comprehensive tool for measuring the most important outcomes and risk factors applicable to a broad variety of diseases.

Main objective of this study is the analysis of quality of life 90 and 360 days after stroke and its association with stroke specific risk factors and complications, also measured within the scope of the ICHOM tool.

Furthermore, the process and success of the implementation of the ICHOM stroke standard set within the stroke unit of the University Medical Centre Hamburg- Eppendorf (UKE) will be studied and evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients in inpatient care in the stroke unit of the UKE with the following diagnoses (ICD-10):
  • Ischemic attack (I63),
  • Transient ischemic attack (G45)
  • Intracerebral hemorrhage (I64)
  • Written informed consent

Exclusion criteria

  • Substantially impaired communication capacity due to aphasia or dementia

Treatment and study plan

PROMS

Other

Introduction and assessment of the ICHOM standard set consisting of demographic and medical data as well as questionnaires filled in by patients, shortly after admission to the stroke unit, at discharge, and at 90 and 360 days after stroke.

Specifically the intervention includes an assembly of clinical records, in particular records of complications, recurrence of disease and mortality. Further patients will be required to complete a questionnaire assessing their situation in terms of housing and symptom burden as well as their self-perceived autonomy and quality of life.

Telephone assessments will be administered to support patients if necessary and validate their responses.

Primary outcomes

  1. Global patient reported health-related quality of life

    Time frame: 90 days

    PROMIS-10

Secondary outcomes

  1. Patient reported mental health status

    Time frame: 90 days

    PHQ-4 (depression, anxiety)

  2. Recurrence of disease

    Time frame: 90 days

    patient-reported measures

  3. Acute complications of treatment

    Time frame: at discharge from inpatient care, on average 6 days after admission

    clinical assessment of symptomatic intracranial hemorrhage

  4. Use of healthcare services after stroke

    Time frame: 90 days

    Patient-reported measures about the patient's level of care and use of specific rehabilitation measures as part of the ICHOM stroke standard set, specifically two questions ranging from 0 to 5 and 0 to 4 with 0 denoting self-containment and no use of rehabilitation services respec-tively and 5 and 4 denoting high level care-dependency and admission in longterm care facilities respectively.

  5. Quantitative process evaluation of the implementation of the ICHOM stroke standard set in routine care

    Time frame: after study completion (2 years)

    Quantitative indicators on feasibility of the intervention (i.e. recruitente and respective response rate)

  6. Psychometric evaluation of the patient-reported outcome measures

    Time frame: after study completion (2 years)

    Psychometric evaluation of the patient-reported outcome measueres of the ICHOM stroke standard set in the study population

  7. Qualitative process evaluation of the implementation of the ICHOM stroke standard set in routine care

    Time frame: after study completion (2 years)

    qualitative interviews with the staff and patients on acceptability, feasibility, barriers, and facilitators of the intervention

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Outcome Evaluation by Patient Reported Outcome Measures (PROMs) in Stroke Clinical Practice - EPOS

Acronym: EPOS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 8, 2019
Registry last updated
Apr 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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